Boston Scientific LATITUDE Programming System Recalled for Stimulation Risk
Boston Scientific is recalling 74 LATITUDE Programming Systems due to a potential for unintended cross-chamber stimulation in pacing devices.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a potential for unintended stimulation, which is a risk-of-harm product where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Boston Scientific Corporation is recalling 74 units of the Model 3300 LATITUDE Programming System. The recall is due to a potential for the Pacing System Analyzer (PSA) to exhibit unintended cross-chamber stimulation.
The LATITUDE Programming System is intended for use in hospital and clinical environments to communicate with Boston Scientific implantable systems. The software controls communication functions for the Pulse Generator (PG). The affected units were distributed worldwide, including in the United States (Florida, Utah, and Virginia) and in Austria, Czech Republic, Germany, Greece, Netherlands, Norway, Portugal, Spain, Sweden, United Kingdom, and Switzerland.
Healthcare providers should identify affected units by checking the serial numbers listed in the recall notice. Patients using these systems should contact their healthcare provider for further instructions.
The recalled product
- Product
- Model 3300 LATITUDE(TM) Programming System Product Usage - The Boston Scientific LATITUDE Programming System is intended for use in hospital and clinical environments to communicate with Boston Scientific implantable systems. The software in use controls all communication…
- Manufacturer
- Boston Scientific Corporation
- Category
- Medical Device — Cardiac Pacing
- Hazard
- Affected units
- 74
Distribution
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